We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Denali (DNLI) Q4 Earnings Beat Estimates, Pipeline in Focus
Read MoreHide Full Article
Denali Therapeutics (DNLI - Free Report) incurred a loss of 75 cents per share for fourth-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of 78 cents, but wider than the year-ago quarter’s loss of 62 cents per share. The recorded loss per share of the company is narrower than our estimate of a loss of 76 cents per share as well.
Collaboration revenues came in at $10.3 million in the reported quarter, surpassing the Zacks Consensus Estimate of $8.03 million and down from $12.5 million in the year-ago period. The decrease was primarily due to a fall in revenues from collaboration with Takeda as the preclinical performance obligations have been met. This decrease was partially offset by an increase in revenues from collaboration with Sanofi (SNY - Free Report) for Alzheimer's Disease program.
Total collaboration revenues also beat our estimate of $7 million.
In the past year, Denali’s shares have lost 17.7% compared with the industry’s 11.8% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses increased to $92.1 million in the quarter under review compared with $67.9 million in the year-ago period.
General and administrative expenses were $23.5 million, up from $21.8 million in the year-ago quarter.
Cash, cash equivalents and marketable securities were approximately $1.34 billion as of Dec 31, 2022, compared with $1.11 billion as of Sep 30, 2022.
2022 Results
Total collaboration revenues for the full year were clocked at $108.5 million, which surpassed the Zacks Consensus estimate and our estimate of $105.33 million and $105.2 million, respectively. Collaboration revenues increased 122.8% from the last year’s figure of $48.7 million.
Loss per share for the full year is $2.60, which is narrower than the Zacks Consensus Estimate and our estimate of a loss of $2.63 and $2.61, respectively. In the year ended 2021, the loss per share of Denali was $2.39.
2023 Financial Guidance
Denali anticipates an increase in cash operating expenses by 25-30% in 2023 from the year-ago period, partially offset by milestone payments received, including $25 million received from Sanofi in January 2023.
Recent Updates
Denali has collaborated with Biogen (BIIB - Free Report) to advance its LRRK2 inhibitor program to address Parkinson’s disease (PD). In October 2022, Denali and Biogen initiated the global phase III LIGHTHOUSE study of BIIB122 in up to 400 participants with PD and a confirmed LRRK2 pathogenic variant. Dosing is ongoing in the global phase IIb LUMA study in up to 640 participants with early-stage Parkinson’s disease.
Denali initiated the recruitment of phase II/III COMPASS study, which is continuing to enroll approximately 54 MPS II (Hunter syndrome) patients. Upon completion of the ongoing phase I/II study and together with data from the global COMPASS study, this combined data package will potentially support registration.
In November 2022, Denali announced interim results from part A of the phase I/II study evaluating TAK-594/DNL593 (PTV:PGRN) in healthy subjects. Data showed that single doses of the candidate increased CSF PGRN level, significantly and was overall well tolerated based on blinded safety analysis. Denali expects the final data from Part A of the study in mid-2023.
The company has also partnered with Sanofi for its two separate receptor-interacting serine/threonine protein kinase 1 (RIPK1) inhibitor programs to address neurological diseases using the central nervous system (CNS)-penetrant RIPK1 inhibitors and peripheral inflammatory diseases using non-CNS penetrant RIPK1 inhibitors.
In January 2023, Denali reported that Sanofi had initiated a phase II study evaluating SAR443820 in multiple sclerosis for which Denali received a milestone payment of $25 million.
Additionally, patient enrollment in the global phase II HIMALAYA study of SAR443820 for patients with amyotrophic lateral sclerosis is expected to be completed by the end of 2023.
Denali Therapeutics Inc. Price, Consensus and EPS Surprise
In the past 90 days, the estimate for Allogene’s 2022 loss per share has been flat at a loss of $2.38. During the same period, the loss estimate per share for 2023 has narrowed from $2.85 to $2.83. In the past year, the shares of Allogene have fallen 26.3%.
ALLO’s earnings witnessed an average earnings surprise of 9.44%, beating all four estimates in the trailing four reported quarters.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Denali (DNLI) Q4 Earnings Beat Estimates, Pipeline in Focus
Denali Therapeutics (DNLI - Free Report) incurred a loss of 75 cents per share for fourth-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of 78 cents, but wider than the year-ago quarter’s loss of 62 cents per share. The recorded loss per share of the company is narrower than our estimate of a loss of 76 cents per share as well.
Collaboration revenues came in at $10.3 million in the reported quarter, surpassing the Zacks Consensus Estimate of $8.03 million and down from $12.5 million in the year-ago period. The decrease was primarily due to a fall in revenues from collaboration with Takeda as the preclinical performance obligations have been met. This decrease was partially offset by an increase in revenues from collaboration with Sanofi (SNY - Free Report) for Alzheimer's Disease program.
Total collaboration revenues also beat our estimate of $7 million.
In the past year, Denali’s shares have lost 17.7% compared with the industry’s 11.8% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses increased to $92.1 million in the quarter under review compared with $67.9 million in the year-ago period.
General and administrative expenses were $23.5 million, up from $21.8 million in the year-ago quarter.
Cash, cash equivalents and marketable securities were approximately $1.34 billion as of Dec 31, 2022, compared with $1.11 billion as of Sep 30, 2022.
2022 Results
Total collaboration revenues for the full year were clocked at $108.5 million, which surpassed the Zacks Consensus estimate and our estimate of $105.33 million and $105.2 million, respectively. Collaboration revenues increased 122.8% from the last year’s figure of $48.7 million.
Loss per share for the full year is $2.60, which is narrower than the Zacks Consensus Estimate and our estimate of a loss of $2.63 and $2.61, respectively. In the year ended 2021, the loss per share of Denali was $2.39.
2023 Financial Guidance
Denali anticipates an increase in cash operating expenses by 25-30% in 2023 from the year-ago period, partially offset by milestone payments received, including $25 million received from Sanofi in January 2023.
Recent Updates
Denali has collaborated with Biogen (BIIB - Free Report) to advance its LRRK2 inhibitor program to address Parkinson’s disease (PD). In October 2022, Denali and Biogen initiated the global phase III LIGHTHOUSE study of BIIB122 in up to 400 participants with PD and a confirmed LRRK2 pathogenic variant. Dosing is ongoing in the global phase IIb LUMA study in up to 640 participants with early-stage Parkinson’s disease.
Denali initiated the recruitment of phase II/III COMPASS study, which is continuing to enroll approximately 54 MPS II (Hunter syndrome) patients. Upon completion of the ongoing phase I/II study and together with data from the global COMPASS study, this combined data package will potentially support registration.
In November 2022, Denali announced interim results from part A of the phase I/II study evaluating TAK-594/DNL593 (PTV:PGRN) in healthy subjects. Data showed that single doses of the candidate increased CSF PGRN level, significantly and was overall well tolerated based on blinded safety analysis. Denali expects the final data from Part A of the study in mid-2023.
The company has also partnered with Sanofi for its two separate receptor-interacting serine/threonine protein kinase 1 (RIPK1) inhibitor programs to address neurological diseases using the central nervous system (CNS)-penetrant RIPK1 inhibitors and peripheral inflammatory diseases using non-CNS penetrant RIPK1 inhibitors.
In January 2023, Denali reported that Sanofi had initiated a phase II study evaluating SAR443820 in multiple sclerosis for which Denali received a milestone payment of $25 million.
Additionally, patient enrollment in the global phase II HIMALAYA study of SAR443820 for patients with amyotrophic lateral sclerosis is expected to be completed by the end of 2023.
Denali Therapeutics Inc. Price, Consensus and EPS Surprise
Denali Therapeutics Inc. price-consensus-eps-surprise-chart | Denali Therapeutics Inc. Quote
Zacks Rank and Stock to Consider
Denali currently has a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Allogene Therapeutics, Inc. (ALLO - Free Report) , carrying a Zacks Ranks #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the estimate for Allogene’s 2022 loss per share has been flat at a loss of $2.38. During the same period, the loss estimate per share for 2023 has narrowed from $2.85 to $2.83. In the past year, the shares of Allogene have fallen 26.3%.
ALLO’s earnings witnessed an average earnings surprise of 9.44%, beating all four estimates in the trailing four reported quarters.